Recall Summary
| Recall number | D-0083-2027 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-10-28 |
| Company | Par Health USA, LLC |
| Units affected | 1,944 |
| Severity | Class I |
Remedy: Follow the instructions in the official notice linked below. The agency record for this recall did not contain remedy text we could verify against this product, so we have not reproduced it here.
Read the official U.S. Food and Drug Administration recall notice
Par Health recall D-0083-2027 covers one lot group of an injectable blood thinner used in hospitals. On October 28, 2026, the U.S. Food and Drug Administration listed a recall of Argatroban Injection from Par Health USA, LLC. The reason is particulate matter found in the drug solution. The FDA rated it Class I, its most serious level. This matters because the drug goes straight into the bloodstream.
What the Par Health Recall Covers
The recalled product is Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL). It comes as a 2.5 mL single-dose vial, one vial per carton. It is a prescription-only drug. The NDC number is 42023-182-89.
The recalled vials carry two labels. One version says “Manufactured for: Endo USA, Malvern, PA 19355.” The other says “Distributed by: Par Pharmaceutical, Cranbury, NJ 08512.” Both versions fall under this Par Health recall. As a result, pharmacy staff should check both label styles when reviewing stock.
The FDA record lists 1,944 units in scope. Lot numbers and expiration dates are not reproduced on this page. However, the official FDA notice is the place to confirm them. You can review it here: FDA Enforcement Report for drugs. Always match the lot printed on the vial against that notice.
Argatroban is typically given in a hospital or clinic setting. It is an anticoagulant, which means it helps prevent blood clots. In most cases, patients never handle the vial themselves. Instead, it is stocked by hospital pharmacies and given by IV under medical supervision.
The Hazard and Reported Injuries
The FDA record says particulate matter was found in the product solution. The particles were identified as cellulose, polystyrene, polyethylene terephthalate, stainless steel, or stopper material. In plain terms, that includes fibers, plastics, metal, and bits of the rubber vial stopper. None of these belong in an injectable drug.
Foreign particles in an IV drug can pose real risks. For example, particles can travel through blood vessels and lodge in small ones. They may cause local irritation or inflammation. In some cases, particles can contribute to blockages in the lungs or other organs. Patients who are already seriously ill may face higher risk.
The FDA classified this Par Health recall as Class I. That class applies when there is a reasonable probability that using the product could cause serious health problems or death. However, the agency record does not say whether any injuries have been reported. We cannot say either way. Anyone with health concerns should speak with their doctor.
| Recall Detail | Information |
|---|---|
| Recall number | D-0083-2027 |
| Issuing agency | U.S. Food and Drug Administration |
| Date | October 28, 2026 |
| Company | Par Health USA, LLC |
| Product | Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), NDC 42023-182-89 |
| Units affected | 1,944 units |
| Severity | Class I |
What To Do If You Own This Product
Most people affected by this Par Health recall will be healthcare facilities, not individual consumers. Hospital pharmacies, clinics, and distributors should check their inventory right away. First, look for NDC 42023-182-89 on the carton or vial. Next, check whether the label reads Endo USA or Par Pharmaceutical. Then compare the lot number with the FDA notice.
If a vial matches, stop using it. Set it apart from other stock so it is not given by mistake. Typically, facilities quarantine recalled drugs until they get return or disposal instructions. Do not throw the product away before reading the official guidance.
This page does not state the remedy for this recall. The agency record contained remedy text that did not match the product, so we left it out. Instead, follow the instructions in the official notice linked on this page. You can also contact Par Health or your drug wholesaler directly for return steps.
Patients have a different role. If you received argatroban during a hospital stay, you likely won’t know the lot number. That is normal. You can ask your care team or the hospital pharmacy whether the recall affected you. If you have symptoms or concerns, talk with a doctor. Adverse reactions can be reported to the FDA through MedWatch.
Does a Par Health Recall Mean You Can Sue?
A recall is not a lawsuit. It is a safety action meant to remove a risky product from use. The FDA lists the recall, and the company carries it out. A recall alone does not create a legal claim. It also does not mean anyone was harmed.
A legal claim usually needs more than a recall notice. Typically, a person must show they actually received the recalled product. They must also show a real injury. In addition, they must show the product likely caused that injury. As a result, medical records and hospital records often matter a great deal.
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We have not verified any lawsuit tied to this Par Health recall. That could change over time, or it may never happen. If you believe you were harmed, a licensed attorney can review your situation. Many product liability lawyers offer free consultations. Depending on the facts, you may be eligible to pursue a claim. However, no outcome is guaranteed.
Timing can also matter. Every state has deadlines, called statutes of limitations, for injury claims. Those deadlines vary widely. For example, some states allow two years, while others allow more or less. An attorney licensed in your state can explain which rules apply. Keep any records you have in the meantime.
How Recalls Connect to Mass Tort Cases
Recalls sometimes become evidence in later litigation. A recall can show that a known defect existed. It can also help set a timeline of when a company learned about a problem. For example, the 2021 Philips CPAP recall involved foam that could break down. That recall was later followed by many lawsuits, which were grouped into federal multidistrict litigation.
Takata airbags offer another well-known example. Defective inflators led to one of the largest auto recalls in U.S. history. Injury lawsuits followed and were also consolidated in federal court. However, many recalls never lead to any litigation at all. In most cases, lawsuits follow only when injuries are documented and linked to the defect. A Par Health recall is a safety notice first, and it should be read that way.
Drug recalls follow a similar pattern. Injectable drug recalls for particulate matter are fairly common across the industry. Most are resolved through returns and replacement stock. As a result, it is too early to predict where this Par Health recall may lead. Readers should watch for official updates rather than rumors.
Frequently Asked Questions
What product is included in the Par Health recall?
The recall covers Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), in 2.5 mL single-dose vials. The NDC is 42023-182-89. Vials may carry either an Endo USA or a Par Pharmaceutical label.
Why was the drug recalled?
The FDA record cites particulate matter in the solution. Particles were identified as cellulose, polystyrene, polyethylene terephthalate, stainless steel, or stopper material. The FDA rated this a Class I recall.
Have any injuries been reported from this Par Health recall?
The agency record does not say whether injuries have been reported. We cannot confirm either way. If you have health concerns after receiving argatroban, talk with your doctor.
What should a hospital do with recalled vials?
Stop using matching vials and set them apart from other stock. Then follow the instructions in the official FDA notice linked on this page. Your wholesaler or Par Health can also help with return steps.
Were You Injured by a Recalled Product?
A recall by itself is a safety action, not a legal claim. However, if a recalled product caused a real injury, you may be eligible to pursue compensation. A licensed attorney can review your situation at no upfront cost — most work on contingency, meaning you pay nothing unless you recover.
Official Sources & Resources
Verify every recall against the issuing agency before acting:
- U.S. Food and Drug Administration: official recall database — the record of truth for this notice
- CPSC: cpsc.gov — household goods, toys, furniture, appliances
- FDA: fda.gov — food, drugs, and medical devices
- NHTSA: nhtsa.gov — vehicles, tires, and child car seats
- USDA FSIS: fsis.usda.gov — meat, poultry, and egg products
Content last reviewed November 2026. This is general educational information, not legal advice. If you notice outdated information, please contact us.
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Attorney Advertising. The information on this page is provided for general informational purposes only and does not constitute legal advice. A product recall is a safety action by a manufacturer or regulator and does not by itself establish liability or create a legal claim. No attorney-client relationship is created by accessing or using this content. Every case is unique. If you believe you were harmed by a recalled product, consult a licensed attorney in your jurisdiction.